GTx, Inc. (Nasdaq: GTXI) announced today that the effects of Ostarine™ (GTx-024) on physical function in patients with non-small cell lung cancer (NSCLC) will be the subject of an oral podium presentation at the 14th Annual World Conference on Lung Cancer, the annual meeting of the International Association for the Study of Lung Cancer being held July 3 – 7 in Amsterdam, The Netherlands. Ostarine is an oral selective androgen receptor modulator (SARM) which GTx is evaluating for the prevention and treatment of muscle wasting in patients with NSCLC.
|Session Info: Oral Session, Palliative and Supportive Care|
|“GTx-024, a selective androgen receptor modulator (SARM), improves physical function in non-small cell lung cancer (NSCLC) patients with muscle wasting.”|
|Day/Date: Monday, July 4, 2011|
|Session Time: 2:30 PM - 4:00 PM|
Additional Ostarine™ Phase IIb study results will be the subject of a poster presentation.
Session Info: Poster Session 3
|“In a Phase IIb trial GTx-024 overcomes the negative impact of >8% weight loss on overall survival in non-small cell lung cancer (NSCLC) subjects.”|
|Day/Date: Wednesday, July 6, 2011|
|Session Time: 12:15 PM - 2:15 PM|
|Room: Exhibition Hall|
About Muscle Wasting, a Common Cancer Related Symptom
Muscle wasting is a common cancer related symptom which can begin early in the course of a patient's malignancy resulting in a decline in physical function and other detrimental clinical consequences. Muscle wasting and muscle weakness are also side effects of many chemotherapy drugs.
At diagnosis, approximately 50% of advanced non-small cell lung cancer (NSCLC) patients have severe muscle loss, and approximately 70% of these patients will lose muscle before death. Muscle weakness and functional limitations are highly prevalent, with 88% of NSCLC patients reporting difficulty climbing stairs, lifting and carrying 10 lbs, walking a quarter mile, or stooping, crouching or kneeling. Muscle loss is a predictor of performance status, tolerability to cancer treatment, progression free survival and overall survival. Limitations in physical function predict the ability of a NSCLC patient to tolerate chemotherapy, and patients with functional limitations are less likely to be offered treatment. Functional status is also a predictor of survival.
While appetite stimulants and nutritional supplements may increase body fat, they have not been shown to increase muscle, improve physical function, or prolong survival in patients with cancer. There are no drugs approved for the prevention and treatment of muscle wasting in patients with cancer.
Ostarine™ is an oral selective androgen receptor modulator that GTx is developing for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer. GTx recently reached agreement with the United States Food and Drug Administration on the Ostarine Phase III clinical development plan, and the company expects to initiate the POWER1 and POWER2 (Prevention And Treatment Of Muscle Wasting in CancER) Phase III clinical trials in July 2011. Assuming enrollment for both studies is completed within one year, GTx expects completion of the two five month studies (last patient last visit) in the fourth quarter of 2012.
To date, GTx has evaluated Ostarine™ in eight clinical trials involving approximately 600 subjects including three efficacy studies. A four month Phase IIb Ostarine™ clinical trial enrolled 159 patients with NSCLC, colorectal cancer, breast cancer, non-Hodgkin's lymphoma, or chronic lymphocytic leukemia. Ostarine treatment compared to placebo resulted in a 1.4 kg increase in lean body mass and increased speed and power in the Stair Climb Test. There was no difference in deaths or serious adverse events among patients receiving placebo or Ostarine™. The most common adverse events reported in the study were anemia, anorexia, fatigue, nausea and upper respiratory tract infections.
At the 2011 Annual Meeting of the American Society of Clinical Oncology (ASCO), GTx presented a subsequent analysis which defined clinical benefit as a 10% improvement in stair climb power. Among the 61 patients with NSCLC enrolled in the Phase IIb clinical trial, 28 had stair climb power assessed at baseline and again at the conclusion of the study at 16 weeks. Seventy-eight percent (78%) of these patients who were treated with Ostarine™ demonstrated clinical benefit, as compared to 30% of the patients receiving placebo (p=0.02). Additional study results GTx presented at the 2011 ASCO Annual Meeting suggests that Ostarine treatment may offer a potential positive effect on survival in NSCLC patients with severe weight loss. In patients with severe weight loss (>8 % at baseline), the 4 month estimated survival was 59% in the placebo group and 83% in patients treated with Ostarine.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules that selectively target hormone pathways for the treatment of cancer, cancer supportive care, and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements include, but are not limited to, statements relating to GTx's plans to initiate clinical trials for Ostarine™ (GTx-024) and statements related to the therapeutic potential of GTx's product candidates. Forward-looking statements involve risks and uncertainties. GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx will not be able to commercialize its product candidates if clinical trials do not demonstrate safety and efficacy in humans; (ii) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; (iii) that clinical trials planned to be conducted by GTx may not be initiated or completed on schedule, or at all, or may otherwise be suspended or terminated; (iv) that GTx could utilize its available cash resources sooner than it currently expects and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs or commercialization efforts. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx's Prospectus Supplement on Form 424B5, filed with the Securities and Exchange Commission on June 23, 2011, contains under the heading, "Risk Factors", a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
McDavid Stilwell, 901-507-2667
Director, Corporate Communications & Financial Analysis
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